Project Management & Clinical Trial Services

At the heart of our program is our commitment to full-service, organized study management. From contract award to study closure, a highly qualified team with extensive training in protocol management, laboratory processes and client relations is responsible for oversight of each study and delivery of accurate data.

clinical_services

  • Clinical trial support services

    • Development and routine maintenance of customized, protocol-specific database.
    • Preparation of customized, visit-specific kits and requisition forms for specimen collection.
    • Preparation of laboratory reports in customized, sponsor-specific format.
    • Customization of flagging specifications (alert values, inclusion/exclusion criteria, etc.).
    • Preparation and distribution of customized investigator manuals.
    • Preparation and distribution of customized collection kits.
    • Shipping of emergency back-up supplies and replacement kits as necessary.
    • Specimen Management: accuracy and acceptability of incoming specimens checked pursuant to regulatory requirements, accreditation standards, and protocol specifications.
    • Investigator support services
    • Helpdesk
    • Remote data access
  • Testing services

    LBM offers a broad array of tests and new procedures are implemented on a regular basis. State-of-the-art technology enables us to perform specialized dosages and tests in different fields of application.

    Methodologies:

    • Enzyme-linked immunosorbent assays (ELISA)
    • Radioimmunoassays (RIA)
    • Immunoradiometric assays (IRMA)
    • Chemiluminescence immunoassays (CLIA)
    • High performance liquid chromatography (HPLC)
    • High performance liquid chromatography tandem mass spectrometry (HPLC-MS/MS)

    Specialties:

    • Clinical chemistry
    • Hematology
    • Immunology
    • Endocrinology
    • Microbiology
    • Virology
    • Toxicology
    • Drug monitoring
    • DNA analysis
  • Specimen Management & Storage

    • Testing performed in a timely and accurate manner
    • Safety testing usually reported within 24-48 hours of receipt of specimen
    • Same-day reporting of pathological results
    • Consistent reference ranges
    • Method validation
    • Short-term or long-term specimen storage at -4ºC, –20ºC or –75ºC on the basis of specific project and/or sponsor needs.
  • Data Management & Archiving

    • Customized Reports and Protocol-specific Database
    • Data Transfer: to sponsor in sponsor-preferred format, scheduled or ad hoc
    • Remote Data Access: secure access to results and reports
    • Development and routine maintenance of customized, protocol-specific database
    • All laboratory data, including hard copies of reports and electronic database, are stored for a total of three years.
    • Length of laboratory data storage time can be extended on the basis of specific project and/or sponsor needs.
  • Reporting

    • Customized laboratory reports in sponsor-specific format
    • Customized flagging specifications (alert values, inclusion/exclusion criteria, etc.)
    • Results reported as single and/or cumulative reports by fax, e-mail or courier service as per specific Study Agreements
    • Secure remote access to results and reports
  • Logistics

    • Courier Services from LBM to Investigator Sites: visit-specific kits and supplies, manuals, shipping supplies & documents
    • Courier services from Investigator Sites to LBM: top bulk couriers for safety testing; all other shipments are tailor-made specialty services, meeting specific timelines
    • Courier services in Argentina, Chile, Uruguay, Colombia, Peru and Brazil